FDA 510(k) Application Details - K991312

Device Classification Name	Elastomer, Silicone, For Scar Management   More FDA Info for this Device
510(K) Number	K991312
Device Name	Elastomer, Silicone, For Scar Management
Applicant	LIBRARY MEDICAL, INC. 60 TERENCE DR. PITTSBURGH, PA 15236 US Other 510(k) Applications for this Company
Contact	RICHARD A HARTMAN Other 510(k) Applications for this Contact
Regulation Number	878.4025   More FDA Info for this Regulation Number
Classification Product Code	MDA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/16/1999
Decision Date	08/20/1999
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review